Solstice Neurosciences, Inc v Allergan, Inc (Corrected Version) - [2006] APO 2

ABSTRACTS OF DECISIONS
DECISION OF A DELEGATE OF THE COMMISSIONER OF PATENTS
Application : No. 755556 in the name of SOLSTICE NEUROSCIENCES, INC

Title: Stable Liquid Formulations of Botulinum Toxin

Action: Opposition under section 59 (Patents Act 1990) by ALLERGAN, INC. Application for an extension of time in which to serve Evidence-in-Answer (regulation 5.10(2)).

Decision: Issued 21 February 2006 .
Abstract

The applicant requested (i) a 3 month extension of time to file Evidence in Answer and (ii) a direction from the Commissioner to defer the final date for filing of Evidence in Answer until determination of the acceptability of S 104 amendments filed with the request for extension of time.
The applicant filed amendments in response to arguments raised by the opponent in an opposition action in Europe and these requests were filed to allow time for the applicant’s expert to consider the amended claims. The delegate, however, considered that these amendments would not alter the case to be answered in the substantive opposition in Australia.
Although the delegate considered that the applicant had shown diligence in filing the amendments within 14 days of the outcome of the EP opposition being known, 18 months had elapsed since the finalizing of the Evidence in Support and the public interest was held not to be served by the further delay arising from the issuing of a direction as requested.
The delegate also considered that despite the absence of any Evidence in Answer having been yet filed, the applicant’s actions in continuing to prosecute the opposition and amending the specification indicated that when filed, it was highly likely that the Evidence in Answer would be directly relevant to the issues raised by the opponent.
The delegate decided, in view of the all the circumstances, and bearing in mind the decision in Race Lotto v AWA Limited [1998] APO 78, that the request to issue a direction be refused, but the 3 month extension be granted to allow the applicant sufficient time to file relevant evidence responding to the Evidence in Support.
Costs were awarded against the applicant.
PATENTS ACT 1990
DECISION OF A DELEGATE OF THE COMMISSIONER OF PATENTS
Re:Patent Application No. 755556 by SOLSTICE NEUROSCIENCES, INC and opposition thereto by ALLERGAN, INC.

BACKGROUND

Patent application 722248 (the application) was filed under the provisions of the PCT as PCT/US99/20912 on 9 September 1999 by ELAN PHARMACEUTICALS, INC. The application entered the national phase in Australia as 58214/99 on 9 April 2001. Examination was requested on 15 October 2001 and the application was advertised accepted on 12 December 2002.
On 12 March 2003 a notice of opposition was lodged by ALLERGAN, INC (Allergan), followed by a statement of grounds and particulars on 16 June 2003. On 3 September 2004, in accordance with a request filed 20 August 2004, the name of the applicant was changed to SOLSTICE NEUROSCIENCES, INC (Solstice).
The opponent (Allergan) completed filing of evidence-in-support on 5 July 2004.
Evidence-in-Answer was originally due to be…

Grounds of appeal

[14] The appellant contends that the primary judge erred in finding that the respondent had discharged the onus of establishing the matters required under the relevant provision.

[15] It was submitted that his Honour failed to give adequate weight to the evidence of the second witness, and that the findings of fact were not reasonably open on the material before the Court.

[16] The respondent, for its part, submits that no error is disclosed, and that the conclusions reached were well within the range of outcomes available to the primary judge.

Consideration

[17] It is convenient to deal first with the question of construction, as the resolution of that issue informs the remaining grounds advanced by the appellant.

[18] For the reasons that follow, we are of the view that the appeal should be allowed in part and the matter remitted for further determination.

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Details

Case: [2006] APO 2
Decision Date: 21 February 2006

CaseChat Overview and Summary

In the case of Solstice Neurosciences, Inc v Allergan, Inc, the applicant sought an extension of time to file Evidence in Answer and a direction to defer the final date for filing such evidence until the outcome of pending amendments to the patent application. The opposition was filed by Allergan, Inc against Solstice Neurosciences, Inc's patent application for stable liquid formulations of botulinum toxin. The legal issues involved the interpretation and application of regulations 5.10(1) and 5.10(2) of the Patents Regulations 1991, which govern extensions of time and directions for the conduct of opposition proceedings.

The delegate considered the nature and significance of the proposed amendments, the timeliness of their filing, and the interests of both parties and the public. The amendments related to changes in claim language and the description of a buffered saline solution. The delegate concluded that the amendments were either trivial or of minor significance and would not substantially affect the case to be answered in the opposition. Although the applicant demonstrated diligence in filing the amendments promptly after the outcome of a related European opposition, the delegate found that the public interest would not be served by further delaying the proceedings. Despite this, the delegate granted the requested three-month extension to allow the applicant sufficient time to file relevant evidence.

The delegate awarded costs against the applicant, finding that the reasons provided for the extension did not justify it, and the opponent's objection was reasonable. This decision highlights the balance required between the interests of the parties and the public in opposition proceedings, and the importance of efficient and expeditious resolution of patent disputes.

Orders